Cost‐effectiveness of elbasvir/grazoprevir use in treatment‐naive and treatment‐experienced patients with hepatitis C virus genotype 1 infection and chronic kidney disease in the United States

Elbasha, Elamin H.; Greaves, Wayne; Roth, David; Nwankwo, Chizoba

doi:10.1111/jvh.12639

Cited by 20 publications

(27 citation statements)

References 57 publications

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“…A paper published by Elbasha et al . (December, 2016) [ 36 ] considered the same objective of our study but in different settings (US settings). The ICUR of EBR/GZR compared with No Treatment was of $13 200/QALY, which is very similar to our findings, despite significant differences in Health care settings.…”

Section: Discussionmentioning

confidence: 99%

“…This published study has been validated by HAS for populating the French cost-utility study. Potential differences in transition probabilities in comparison to other models [ 36 ] are taken into account through deterministic and probabilistic sensitivity analyses, which consider ranges of values for each transition probability and subsequent variation of ICUR highlighted by the tornado chart ( Fig 3 ), the Cost-Utility plane ( Fig 4 ), and the multi-options acceptability frontier ( Fig 5 ).…”

Section: Discussionmentioning

confidence: 99%

“…The adjusted mean HR is estimated at 1.70 with a 95% confidence interval between 1.20 and 2.39. Thus, it is considered in the base case analysis of the model that the presence of chronic hepatitis C in patients with renal insufficiency increases the risk of progression from severe renal insufficiency (stage 4) to end-stage renal failure (stage 5), and from end stage renal failure to hemodialysis, of 1.70, compared to the natural course of renal failure without hepatitis C. The value of 1.32 published for the US model [ 36 ] is included in the 95% CI values which were taken into account in deterministic and probabilistic sensitivity analyses.…”

Section: Discussionmentioning

confidence: 99%

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Cost-effectiveness analysis of elbasvir-grazoprevir regimen for treating hepatitis C virus genotype 1 infection in stage 4-5 chronic kidney disease patients in France

Maunoury¹,

Clément

Nwankwo

et al. 2018

PLoS ONE

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ObjectiveTo assess the cost-effectiveness of the elbasvir/grazoprevir (EBR/GZR) regimen in patients with genotype 1 chronic hepatitis C virus (HCV) infection with severe and end-stage renal disease compared to no treatment.DesignThis study uses a health economic model to estimate the cost-effectiveness of treating previously untreated and treatment experienced chronic hepatitis C patients who have severe and end stage renal disease with the elbasvir-grazoprevir regimen versus no treatment in the French context. The lifetime homogeneous markovian model comprises of forty combined health states including hepatitis C virus and chronic kidney disease. The model parameters were from a multicentre randomized controlled trial, ANRS CO22 HEPATHER French cohort and literature. 1000 Monte Carlo simulations of patient health states for each treatment strategy are used for probabilistic sensitivity analysis and 95% confidence intervals calculations. The results were expressed in cost per quality-adjusted life year (QALY) gained.PatientsThe mean age of patients in the HEPATHER French cohort was 59.6 years and 56% of them were men. 22.3% of patients had a F0 fibrosis stage (no fibrosis), 24.1% a F1 stage (portal fibrosis without septa), 7.1% a F2 stage (portal fibrosis with few septa), 21.4% a F3 stage (numerous septa without fibrosis) and 25% a F4 fibrosis stage (compensated cirrhosis). Among these HCV genotype 1 patients, 30% had severe renal impairment stage 4, 33% had a severe renal insufficiency stage 5 and 37% had terminal severe renal impairment stage 5 treated by dialysis.InterventionFixed-dose combination of direct-acting antiviral agents elbasvir and grazoprevir compared to no-treatment.ResultsEBR/GZR increased the number of life years (6.3 years) compared to no treatment (5.1 years) on a lifetime horizon. The total number of QALYs was higher for the new treatment because of better utility on health conditions (6.2 versus 3.7 QALYs). The incremental cost-utility ratio (ICUR) was of €15,212 per QALY gained for the base case analysis.ConclusionsThis cost-utility model is an innovative approach that simultaneously looks at the disease evolution of chronic hepatitis C and chronic kidney disease. EBR/GZR without interferon and ribavirin, produced the greatest benefit in terms of life expectancy and quality-adjusted life years (QALY) in treatment-naïve or experienced patients with chronic hepatitis C genotype 1 and stage 4–5 chronic kidney disease including dialysis patients. Based on shape of the acceptability curve, EBR/GZR can be considered cost-effective at a willingness to pay of €20,000 /QALY for patients with renal insufficiency with severe and end-stage renal disease compared to no treatment.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Cost-effectiveness analysis of elbasvir-grazoprevir regimen for treating hepatitis C virus genotype 1 infection in stage 4-5 chronic kidney disease patients in France

Maunoury¹,

Clément

Nwankwo

et al. 2018

PLoS ONE

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“…However, restricting treatment to those with advanced liver disease fails to consider the benefits that earlier treatment may have in preventing fibrosis and cirrhosis . Although DAA therapies remain costly, recent analyses suggested that grazoprevir/elbasvir was cost‐effective among American patients with nondialysis dependent CKD, and among French patients with stages 4 and 5 (dialysis depenedent) CKD . Indeed, some now suggest that all patients with ESRD should be considered candidates for DAAs .…”

Section: Treatmentmentioning

confidence: 99%

Hepatitis C virus infection in patients with end‐stage renal disease

Wigneswaran¹,

Wyck

Pegues

et al. 2018

Hemodialysis International

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Chronic hepatitis C virus (HCV) infection is a major global health problem affecting 3-5 million people in the United States and over 100 million worldwide. Chronic HCV infection, which can lead to cirrhosis and hepatocellular carcinoma, also results in numerous other complications, including impairment of renal function. Because HCV is most often transmitted via parenteral exposure to blood or blood products, patients with end-stage renal disease (ESRD) treated with hemodialysis are at particular risk for infection. Historically, the medications available to treat HCV infection in these patients had significant side effects and were not particularly effective in generating a sustained virologic response. Since 2011, a number of direct-acting antiviral therapies have emerged that can lead to virological cure in the vast majority of patients, with low pill burden and few side effects. Here, we describe the biology and pathophysiology of HCV infection, and summarize current information on new therapies, with a particular focus on their application in patients with chronic kidney disease including ESRD.

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“…For example, in the USA the cost for 12 weeks of treatment per patient, for different DAAs regimens, ranges between 55,000 and 150,000 USD regarding wholesale acquisition prices [18] and reaches a median cost of 113,400 USD in a real-world analysis [8] . However, several analyses conducted in the USA [19,20] have assumed that DAA treatment is cost-effective, especially in patients with less prominent liver fibrosis. But the high cost of therapy limits reimbursement for drugs only to advanced liver disease and to patients with transplanted organs in the USA [8] and some countries in Western Europe [6] .…”

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confidence: 99%

Hepatitis C Virus and Kidney Disease: Evidence, Hope, and Hurdles

Bikbov

2017

Nephron

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Cost‐effectiveness of elbasvir/grazoprevir use in treatment‐naive and treatment‐experienced patients with hepatitis C virus genotype 1 infection and chronic kidney disease in the United States

Cited by 20 publications

References 57 publications

Cost-effectiveness analysis of elbasvir-grazoprevir regimen for treating hepatitis C virus genotype 1 infection in stage 4-5 chronic kidney disease patients in France

Cost-effectiveness analysis of elbasvir-grazoprevir regimen for treating hepatitis C virus genotype 1 infection in stage 4-5 chronic kidney disease patients in France

Hepatitis C virus infection in patients with end‐stage renal disease

Hepatitis C Virus and Kidney Disease: Evidence, Hope, and Hurdles

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